This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ziagen (Abacavir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (80)
Death (13)
Life Threatening Events (16)
Disability (3)
Reports by Reaction Type
Abortion Spontaneous (13),
Renal Failure Acute (12),
Death (10),
Maternal Exposure During Pregnancy (10),
Exomphalos (8),
Renal Tubular Disorder (7),
Pyrexia (7),
Rash (7),
Foetal Exposure During Pregnancy (6),
Coronary Artery Occlusion (6),
Hyperphosphaturia (5),
Liver Disorder (5)
Below are a few examples of reports where side effects / adverse reactions may be related to Ziagen (Abacavir). For a complete list or a specific selection of reports, please use the links above.
Possible Ziagen side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Hypersensitivity, Angioedema
Drug(s) suspected as cause:
Ziagen
Other drugs received by patient: Nifedipine; Epzicom; Lipitor; Isentress
Possible Ziagen side effects in 24 year old male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 24 year old male
Reactions: Pulmonary Hypertension, Palpitations, Dizziness
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Crixivan
Administration route: Oral
Indication: HIV Infection
Start date: 2000-03-18
End date: 2000-05-24
Efavirenz
Dosage: interrupted from 07/25/00 to 09/25/00 24jul-25jul2000,25sep-02oct2000. film coated tab 200 mg
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2000-10-02
Epivir
Dosage: tabs
Administration route: Oral
Indication: HIV Infection
Start date: 2004-05-15
End date: 2008-09-19
Invirase
Dosage: inter:03/18/00-05/24/00,caps 800mg:19jun99-18mar2000.divided dse:24may00-24dec2000,19jun1999-24dc00
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2001-03-31
Kaletra
Dosage: 1df,25dec2000-24apr2004:1217 days
Administration route: Oral
Indication: HIV Infection
Start date: 2000-12-25
End date: 2004-04-24
Norvir
Dosage: 31mar2001(interrupted).caps 800mg:19jun99-31oct-99.divided dose:01nov99-24dec2000.25apr2004
Administration route: Oral
Indication: HIV Infection
Start date: 1999-06-19
End date: 2008-09-19
Videx
Dosage: 250,300,400mg12/19/94-3/7/97,3/07/97-7/21/01,7/21/01,125mg,19dc94-7mar97(810d),7mr97-21jl01(1598d)
Administration route: Oral
Indication: HIV Infection
Start date: 1994-12-19
End date: 2001-07-21
Videx EC
Dosage: divided dose
Administration route: Oral
Indication: HIV Infection
Start date: 2001-07-21
End date: 2004-05-14
Zerit
Dosage: 60 mg 8/25/97-27/2/98, 80 mg 2/27-8/3/98, 11/9/98 -6/19/99 and 12/25/00-10/20/01
Administration route: Oral
Indication: HIV Infection
Start date: 1997-08-25
End date: 2001-10-20
Ziagen
Dosage: interrupted from 07/25/00 to 10/20/01 tabs24jul-25jul2000.20oct2001-27oct2001.
Administration route: Oral
Indication: HIV Infection
Start date: 2000-07-24
End date: 2001-10-27
Other drugs received by patient: Cross Eight M
Possible Ziagen side effects in male
Reported by a physician from United States on 2012-08-14
Patient: male, weighing 84.8 kg (186.6 pounds)
Reactions: Product Substitution Issue, Abdominal Distension
Drug(s) suspected as cause:
Ziagen
Possible Ziagen side effects in
Reported by a physician from United States on 2012-08-10
Patient:
Reactions: Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: unk
Administration route: Oral
Sustiva
Dosage: 400 mg, qpm
Administration route: Oral
Ziagen
Dosage: 300 mg, bid
Administration route: Oral
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-08-09
Patient: male
Reactions: Coronary Artery Occlusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Norvir
Dosage: 100mg twice per day
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Prezista
Dosage: 600mg twice per day
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Dosage: 300mg per day
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Viread; Enalapril Maleate
Possible Ziagen side effects in female
Reported by a physician from France on 2012-08-09
Patient: female
Reactions: Lipoma, Lipohypertrophy
Drug(s) suspected as cause:
Videx
Administration route: Oral
Indication: HIV Infection
Start date: 2000-01-01
End date: 2009-01-01
Zerit
Dosage: 30mg twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 1997-01-01
End date: 2009-01-01
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2000-01-01
Other drugs received by patient: Diltiazem HCL; Aspirin; Atorvastatin
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-08-06
Patient: male, weighing 72.0 kg (158.4 pounds)
Reactions: Coronary Artery Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Darunavir Ethanolate
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Norvir
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril Maleate; Viread; Chlorthalidone
Possible Ziagen side effects in male
Reported by a physician from United States on 2012-08-03
Patient: male
Reactions: Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Dosage: tabs
Administration route: Oral
Sustiva
Dosage: dose reduced
Ziagen
Administration route: Oral
Possible Ziagen side effects in
Reported by a physician from United States on 2012-07-31
Patient:
Reactions: Condition Aggravated
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Sustiva
Dosage: 400 mg, qd
Indication: Product Used FOR Unknown Indication
Ziagen
Dosage: 300 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Ziagen side effects in 57 year old female
Reported by a physician from United States on 2012-07-30
Patient: 57 year old female
Reactions: Myocardial Infarction, Arrhythmia
Adverse event resulted in: death
Drug(s) suspected as cause:
Ziagen
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-07-27
Patient: male
Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Norvir
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Prezista
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril Maleate; Viread
Possible Ziagen side effects in 50 year old male
Reported by a physician from Japan on 2012-07-26
Patient: 50 year old male, weighing 52.0 kg (114.4 pounds)
Reactions: Tubulointerstitial Nephritis, Hallucination
Drug(s) suspected as cause:
Atazanavir
Dosage: 300mg per day
Administration route: Oral
Start date: 2010-08-01
Atazanavir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2010-08-01
Efavirenz
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2005-07-01
Epivir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2010-08-01
Epivir
Dosage: 150mg per day
Administration route: Oral
Start date: 2010-08-01
Retrovir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2005-07-01
Ritonavir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2010-08-01
Ritonavir
Dosage: 100mg per day
Administration route: Oral
Start date: 2010-08-01
Tenofovir Disoproxil Fumarate
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2008-11-01
Ziagen
Dosage: 600mg per day
Administration route: Oral
Start date: 2010-08-01
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2008-11-01
End date: 2010-08-01
Possible Ziagen side effects in 81 year old female
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: 81 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Epivir
Dosage: 150mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-01
End date: 2012-07-01
Ziagen
Dosage: 600mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2011-01-01
End date: 2012-07-01
Other drugs received by patient: Diabetes Medication; Heart Medication; Reyataz; Blood Pressure Medication
Possible Ziagen side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-13
Patient: male
Reactions: Liver Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isentress
Indication: Product Used FOR Unknown Indication
Sustiva
Dosage: 400mg at night
Indication: Product Used FOR Unknown Indication
Ziagen
Dosage: 300mg twice per day
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Polypharmacy
Possible Ziagen side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-12
Patient: male, weighing 72.0 kg (158.4 pounds)
Reactions: Coronary Artery Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Darunavir Hydrate
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Norvir
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril Maleate; Chlorthalidone; Viread
Possible Ziagen side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-09
Patient: 57 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ziagen
Possible Ziagen side effects in 48 year old male
Reported by a consumer/non-health professional from France on 2012-07-09
Patient: 48 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Renal Tubular Disorder, Crystal Urine
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Administration route: Oral
Start date: 2008-12-01
Lasix
Norvir
Administration route: Oral
Start date: 2009-09-01
End date: 2010-10-04
Prednisolone
Administration route: Oral
Start date: 2008-11-01
End date: 2010-10-04
Ramipril
Reyataz
Administration route: Oral
Start date: 2009-09-01
End date: 2010-10-04
Ziagen
Administration route: Oral
Start date: 2008-12-01
Other drugs received by patient: Gaviscon; Eupressyl; Lercanidipine; Atenolol; Ramipril; Ferrous Sulfate TAB; Hyperium; Pantoprazole Sodium; Crestor
Possible Ziagen side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06
Patient: 57 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Ziagen
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-07-05
Patient: male
Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Norvir
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Prezista
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril Maleate; Viread
Possible Ziagen side effects in male
Reported by a physician from France on 2012-06-27
Patient: male, weighing 63.0 kg (138.6 pounds)
Reactions: Renal Tubular Disorder, Renal Impairment, Renal Failure Acute, Diabetes Mellitus Inadequate Control, Crystal Urine
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Administration route: Oral
Indication: HIV Infection
Start date: 2008-12-01
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-01
End date: 2010-10-04
Prednisolone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-11-01
End date: 2010-10-04
Reyataz
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-01
End date: 2010-10-04
Ziagen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-12-01
Other drugs received by patient: Atenolol; Crestor; Gaviscon; Lasix; Ramipril; Hyperium; Pantoprazole Sodium; Lercanidipine; Eupressyl; Ferrous Sulfate TAB
Possible Ziagen side effects in 48 year old male
Reported by a consumer/non-health professional from France on 2012-06-27
Patient: 48 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Renal Tubular Disorder, Crystal Urine
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Administration route: Oral
Start date: 2008-12-01
Lasix
Norvir
Administration route: Oral
Start date: 2009-09-01
End date: 2010-10-04
Prednisolone
Administration route: Oral
Start date: 2008-11-01
End date: 2010-10-04
Ramipril
Reyataz
Administration route: Oral
Start date: 2009-09-01
End date: 2010-10-04
Ziagen
Administration route: Oral
Start date: 2008-12-01
Other drugs received by patient: Atenolol; Lercanidipine; Hyperium; Pantoprazole Sodium; Ferrous Sulfate TAB; Eupressyl; Gaviscon; Ramipril; Crestor
Possible Ziagen side effects in male
Reported by a physician from France on 2012-06-26
Patient: male, weighing 63.0 kg (138.6 pounds)
Reactions: Renal Tubular Disorder, Renal Impairment, Diabetes Mellitus, Renal Failure Acute, Crystal Urine
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Administration route: Oral
Indication: HIV Infection
Start date: 2008-12-01
Norvir
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-01
End date: 2010-10-04
Prednisolone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-11-01
End date: 2010-10-04
Reyataz
Administration route: Oral
Indication: HIV Infection
Start date: 2009-09-01
End date: 2010-10-04
Ziagen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-12-01
Other drugs received by patient: Lercanidipine; Hyperium; Lasix; Eupressyl; Pantoprazole Sodium; Crestor; Atenolol; Ramipril; Ferrous Sulfate TAB; Gaviscon
Possible Ziagen side effects in female
Reported by a physician from France on 2012-06-21
Patient: female
Reactions: Metabolic Acidosis, Fanconi Syndrome, Hypokalaemia, Hyperphosphaturia, Glycosuria, Nephropathy, Hyperchloraemia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvir
Dosage: 1unit per day
Administration route: Oral
Indication: HIV Infection
Start date: 2010-01-18
End date: 2011-09-14
Reyataz
Dosage: 300mg per day
Administration route: Oral
Indication: HIV Infection
Start date: 2010-01-18
End date: 2011-09-14
Truvada
Dosage: 1unit per day
Administration route: Oral
Indication: HIV Infection
Start date: 2010-01-18
End date: 2011-09-14
Ziagen
Dosage: 1unit twice per day
Administration route: Oral
Indication: HIV Infection
Start date: 2010-01-18
Possible Ziagen side effects in female
Reported by a physician from France on 2012-06-19
Patient: female
Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Renal Failure Acute, Nephropathy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Reyataz
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Truvada
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Ziagen
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Other drugs received by patient: Ziagen; Epivir; Isentress
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-06-18
Patient: male, weighing 72.0 kg (158.4 pounds)
Reactions: Coronary Artery Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Darunavir Hydrate
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Norvir
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Viread; Chlorthalidone; Enalapril
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-06-15
Patient: male
Reactions: Coronary Artery Occlusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Norvir
Dosage: 100mg twice per day
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Prezista
Dosage: 600mg twice per day
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-10-30
Ziagen
Dosage: 300mg per day
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril; Viread
Possible Ziagen side effects in male
Reported by a consumer/non-health professional from Russian Federation on 2012-06-11
Patient: male
Reactions: Haemorrhoids, Insomnia, Pyrexia, Urinary Retention, Delirium, Hallucination
Drug(s) suspected as cause:
Efavirenz
Dosage: 1tab per day
Administration route: Oral
Indication: HIV Infection
Epivir
Dosage: 1tab per day
Administration route: Oral
Indication: HIV Infection
Reyataz
Administration route: Oral
Indication: HIV Infection
Ritonavir
Administration route: Oral
Indication: HIV Infection
Ziagen
Dosage: 600mg per day
Administration route: Oral
Indication: HIV Infection
Possible Ziagen side effects in male
Reported by a physician from Italy on 2012-06-11
Patient: male
Reactions: Coronary Artery Occlusion, Arteriosclerosis Coronary Artery
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Norvir
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Prezista
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Ziagen
Administration route: Oral
Indication: Acute HIV Infection
Start date: 2006-10-30
End date: 2011-12-23
Other drugs received by patient: Enalapril Maleate; Viread
Possible Ziagen side effects in female
Reported by a physician from France on 2012-06-06
Patient: female
Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Renal Failure Acute, Nephropathy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Reyataz
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Truvada
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Ziagen
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Other drugs received by patient: Epivir; Isentress; Ziagen
Possible Ziagen side effects in female
Reported by a physician from France on 2012-06-06
Patient: female
Reactions: Renal Tubular Disorder, Metabolic Acidosis, Fanconi Syndrome, Hyperphosphaturia, Glycosuria, Amino Acid Level Increased, Nephropathy, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvir
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Reyataz
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Truvada
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Ziagen
Administration route: Oral
Indication: HIV Test Positive
Start date: 2010-01-18
End date: 2011-09-14
Other drugs received by patient: Ziagen; Isentress; Epivir
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